Anvil assembly and delivery system

ABSTRACT

An anvil assembly suitable for trans-oral delivery includes an anvil head configured to receive a guide suture that is severed during a stapling procedure. An anvil delivery assembly includes the anvil assembly and a suture guide assembly secured to the anvil assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation and claims the benefit of and priority to U.S.patent application Ser. No. 14/078,814, filed Nov. 13, 2013, the entiredisclosure of which is incorporated by reference herein.

BACKGROUND

Technical Field

The present disclosure relates to an anvil assembly for use with asurgical stapling device. More particularly, the present disclosurerelates to an anvil assembly and a system for trans-oral delivery of theanvil assembly.

Background of Related Art

Anastomosis is the surgical joining of separate hollow organ sections toallow the sections to communicate with each other. Typically, ananastomosis procedure follows surgery in which a diseased or defectivesection of hollow tissue is removed and the remaining end sections areto be joined. Depending on the desired anastomosis procedure, the endsections of the hollow organ may be joined using circular, end-to-end,end-to-side, or side-to-side organ reconstruction methods.

In a circular anastomosis procedure, the two ends of the organ sectionsare joined by means of a surgical stapling instrument which drives acircular array of staples through the organ end sections and cores andremoves any overlapping tissue to free a tubular passage. In someapplications of a circular anastomosis procedure, an anvil rod having anattached anvil head is mounted to the distal end of a surgical staplinginstrument shaft prior to insertion of the instrument into the tissue tobe anastomosed. However, in other applications, a detachable anvil rodmay be mounted to the instrument subsequent to positioning of thesurgical stapling instrument and the anvil assembly within respectivetissue sections. In such instances, the surgical stapling instrument andthe anvil assembly are separately delivered to the operative site. Eachtissue end section is then secured to a respective anvil or stapleholding component, e.g., by a purse string suture. The anvil assembly ismounted to the surgical stapling instrument by inserting a mountingportion of the anvil rod within the distal end of the surgical staplinginstrument so that a mounting mechanism within the surgical staplinginstrument securely engages the anvil rod. Preparation of the tissuesections to be joined and mounting of the anvil rod to the surgicalstapling instrument may be performed using minimally invasive surgicaltechniques, i.e., under laparoscopic guidance.

An anvil assembly delivery system for delivering an anvil assemblytrans-orally to a surgical site, e.g., the stomach, is disclosed incommonly owned U.S. Pat. No. 8,109,426, the content of which isincorporated herein by reference in its entirety. As described, a guidesuture is threaded through openings in the head of the anvil assembly tofacilitate trans-oral insertion of the anvil assembly and to allowretrieval of the anvil assembly prior to attachment of the anvilassembly to the surgical stapling instrument. At any point during thestapling procedure, the guide suture may be detached from the anvilassembly by pulling the guide suture back through the openings in theanvil head.

To prevent premature detachment of the guide suture from the anvilassembly during trans-oral insertion, it would be beneficial to have ananvil assembly that is configured such that the guide suture remainsattached to the anvil assembly until the stapling procedure is compete,i.e., after the tissue to be anastomosed has been stapled and cut.

SUMMARY

In accordance with the present disclosure, an anvil assembly is providedfor use with a surgical stapling instrument for performing end-to-endanastomosis of tissue. The anvil assembly includes an anvil center rod,and a head assembly pivotally secured to the anvil center rod about apivot axis and movable between an operative position and a tiltedposition. The head assembly includes an anvil head and a cutting ringdisposed within the anvil head. The anvil head defines first and secondopenings and the cutting ring defining a slot in alignment with thefirst and second openings.

In one embodiment, the first and second openings and the slot aredimensioned to receive a suture. The anvil center rod may include firstand second slide members. The first slide member may be pivotallyconnected to the head assembly on one side of the pivot axis by a firstdrive link and the second slide member being connected to the headassembly on the other side of the pivot axis by a second drive link. Thefirst slide member may be movable in relation to the second slide memberto effect movement of the head assembly between the operative positionand the tilted position. The anvil assembly may further include abiasing member positioned to urge the first slide member in relation tothe second slide member to position the head assembly in the tiltedposition. The biasing member may be positioned between the first memberand the second slide member to urge the first and second slide membersapart.

Also provided is an anvil delivery system including an anvil assemblyand a suture guide assembly. The suture guide assembly includes a guidesuture secured to the head assembly and a reel assembly configured forselectively dispensing the guide suture. The guide suture may bereceived through the first opening in the anvil head, passes through theslot in the cutting ring, and extends from the second opening in theanvil head. The reel assembly may include a housing and a reel memberrotatably received within the housing. The guide suture may be supportedabout the reel member. The reel member may define an annular channel forreceiving the guide suture. The housing may define an annular cavity.The reel member may be rotatably supported on the housing within theannular cavity.

In some embodiments, the anvil delivery system may further include atubular guide assembly for trans-oral insertion of the anvil assembly.The tubular guide assembly may include a flexible tube and an adapterconfigured for operably connecting the flexible tube to the anvil centerrod. The tubular guide assembly may further include a retaining suturefor retaining the head assembly of the anvil assembly in the tiltedposition. The retaining suture may be received through third and fourthopenings in the anvil head and may be secured between the adapter andthe flexible tube.

Also provided is an anvil delivery kit. The kit including an anvilassembly, a suture guide assembly including a guide suture and a reelassembly, and a tubular guide assembly including a flexible tube and anadapter.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed surgical stapling instrument,anvil assembly, and anvil delivery system are described hereinbelow withreference to the drawings wherein:

FIG. 1 is a top side perspective view from the proximal end of thepresently disclosed surgical stapling device in the unapproximatedposition;

FIG. 2 is a top side perspective view from the distal end of thesurgical stapling device shown in FIG. 1;

FIG. 3 is a side cross-sectional view of the distal end of the centralbody portion and distal head portion of the surgical stapling deviceshown in FIGS. 1 and 2, with the anvil assembly removed;

FIG. 4 is a side exploded perspective view of the distal head portion,anvil retainer assembly and pusher back of the surgical stapling deviceshown in FIGS. 1 and 2;

FIG. 5 is a perspective view from the proximal end of the anvil assemblyof the surgical stapling device shown in FIGS. 1 and 2, with the anvilhead in a tilted reduced profile position;

FIG. 6 is a perspective view of the anvil assembly shown in FIG. 5 withthe anvil head in the tilted reduced profile position and the anvilplate and cover removed;

FIG. 7 is an exploded side perspective view of the anvil assembly shownin FIG. 5;

FIG. 8 is a side view of an anvil delivery system, including a tubularguide assembly and a suture guide assembly, attached to the anvilassembly shown in FIG. 5, with the anvil head positioned in the tiltedreduced profile position;

FIG. 9 is an enlarged view of the indicated area of detail shown in FIG.8;

FIG. 10 is an enlarged perspective view of a tubular member and anadapter of the tubular guide assembly shown in FIG. 8;

FIG. 11 is an side view of the anvil delivery system shown in FIG. 8,including the anvil assembly shown in FIGS. 5-7 shown in the firsttilted position and a first suture;

FIG. 12 is a side cross-sectional view taken along section line 12-12 ofFIG. 11;

FIG. 13 is a top view of a housing of the suture reel of the sutureguide assembly shown in FIG. 8;

FIG. 14 is a side cross-sectional view of the housing shown in FIG. 14;

FIG. 15 is a top view of a reel member of the reel assembly of thesuture guide assembly shown in FIG. 8;

FIG. 16 is a side cross-sectional view of the reel member shown in FIG.15;

FIG. 17 is a perspective view of the suture guide assembly of the anvildelivery system shown in FIG. 8 attached to the anvil assembly shown inFIG. 5;

FIG. 18 is a cross-sectional view taken along section line 18-18 of FIG.17;

FIG. 19 is an enlarged view of indicated area of detail shown in FIG.18;

FIG. 20 is an illustration of the surgical stapling device shown inFIGS. 1 and 2 inserted into a stomach of a patient and the anvildelivery system with the connected anvil assembly shown in FIG. 8 beinginserted trans-orally into a patient;

FIG. 21 is side cross-sectional view of the distal end of the centralbody portion and distal head portion of the surgical stapling device andthe anvil assembly shown in FIG. 1 with the anvil assembly in itsunapproximated position and the anvil head in the operative position;

FIG. 22 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 21 ninety-degrees offsetfrom the cross-sectional view of FIG. 21;

FIG. 23 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 21 with the anvil head inthe approximated position;

FIG. 24 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 22 ninety-degrees offsetfrom the cross-sectional view of FIG. 23 with the anvil head in theapproximated position;

FIG. 25 is a cross-sectional side view of the anvil assembly shown inFIG. 24 with the distal end portion of the surgical stapling deviceincluding a knife blade shown in phantom during firing of the staplingdevice;

FIG. 26 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 23 with the anvil head inthe approximated position after the stapling device has been fired;

FIG. 27 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 24 offset ninety degreesfrom the cross-sectional view of FIG. 26 after the stapling device hasbeen fired; and

FIG. 28 is a cross-sectional view of the distal end of the central bodyportion and distal head portion shown in FIG. 27 after the anvil headhas been unapproximated and pivoted to the tilted position.

DETAILED DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed surgical stapling device, anvilassembly, and anvil delivery system will now be described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. As iscommon in the art, the term “proximal” refers to that part or componentcloser to the user or operator, i.e. surgeon or clinician, while theterm “distal” refers to that part or component further away from theuser.

Referring to FIGS. 1 and 2, a surgical stapling instrument including ananvil assembly according to the present disclosure is shown generally asstapling device 10. Briefly, stapling device 10 includes a proximalhandle assembly 12, an elongated central body portion 14 including acurved elongated outer tube 14 a, and a distal head portion 16. Handleassembly 12 includes a stationary handle 18, a firing trigger 20, arotatable approximation knob 22, and an indicator 24. A pivotallymounted trigger lock 26 is fastened to handle assembly 12 and ismanually positioned to prevent inadvertent firing of stapling device 10.Indicator 24 is positioned on the stationary handle 18 and includesindicia, e.g., color coding, alpha-numeric labeling, etc., to identifyto a surgeon whether the device is approximated and is ready to befired. Head portion 16 includes an anvil assembly 100 and a shellassembly 30. The structure and function of stapling device 10 will onlybe described to the extent necessary to fully disclose the operation ofanvil assembly 100. For a more detailed description of an exemplarystapling device, please refer to commonly owned U.S. Pat. No. 7,364,060,(“the '060 patent”) the content of which is incorporated herein byreference in its entirety.

Although a manual handle assembly is described, the surgical staplingdevice may be a powered (e.g., motor operated) surgical instrument, orpart of a robotic surgical system, in any of the embodiments disclosedherein.

With reference now to FIGS. 3 and 4, distal end portion 16 of staplingdevice 10 includes shell assembly 30 which is secured to a distal end ofthe central body portion 14, a pusher 40 extending distally throughcentral body portion 14, and an anvil retainer assembly 50 extendingthrough pusher 40 and shell assembly 30. Although not shown, anvilretainer assembly 50 is operably connected to an approximation mechanismof stapling device 10 which is actuated by the rotatable approximationknob 22 (FIG. 1), and pusher 40 is operably connected to a firingmechanism of stapling device 10 which is actuated by the firing trigger20 (FIG. 1). For a more detailed description of the approximationmechanism and/or the firing mechanism of the stapling device 10, see the'060 patent which has been incorporated herein by reference.

Shell assembly 30 includes a shell or housing 32, a pusher back 34, astaple guide 36, a cylindrical knife 38 (FIG. 25), and a plurality ofstaples “S”. Shell 32 includes an outer housing portion 32 a and aninner housing portion 32 b (FIG. 3). Staple guide 36 is supported in thedistal end of outer housing portion 32 a and includes an annular arrayof staple receiving pockets 36 a for housing staples “S”. Pusher back 34is slidably supported in shell 32 between outer housing portion 32 a andinner housing portion 32 b and includes a plurality of fingers 34 awhich are each slidably received in respective staple pockets 36 a instaple guide 36. Pusher back 34 includes a pair of recesses 35 whichreceive detents 42 a formed on flexible fingers 42 of a pusher 40 tosecure pusher 40 to pusher back 34 such that pusher back 34 is movablewith pusher 40 from a retracted position to an advanced position toeject staples “S” from staple guide 36.

In any of the embodiments disclosed herein, the shell assembly may beconfigured as a removable and replaceable assembly. In this way, afterthe staples are fired, the shell assembly can be replaced, providing anew set of staples, even staples of a different size or configuration,and a fresh knife.

An elongated hollow bushing 44 is fixedly retained in inner housingportion 32 b of shell 32 using, e.g., screw threads, a friction fitting,or the like. Bushing 44 defines a channel 45 through which anvilretainer assembly 50 and anvil center rod 160 reciprocate duringapproximation and separation of anvil assembly 100 and shell assembly30. Bushing 44 provides additional strength to inner housing portion 32b of shell 32 to prevent separation of the anvil assembly 100 and anvilretainer assembly 50 during firing of the stapling device 10.

Anvil retainer assembly 50 includes a two-part assembly having a bodyportion 52 defining a longitudinal throughbore 53 and a trocar orlocking member 54 slidably received within longitudinal throughbore 53.Longitudinal throughbore 53 includes a stepped portion or shoulder 53 a(FIG. 3).

Trocar 54 includes an annular flange or shoulder 54 a on a proximal endand a blunt tip 54 b on a distal end. Tip 54 b of trocar 54 extends fromthe distal end of body portion 52 of anvil retainer assembly 50 and ismovable within throughbore 53 of body portion 52 from an advancedposition to a retracted position. A biasing member, e.g., a coil spring56, is positioned between annular flange 54 a and shoulder 53 a oflongitudinal bore 53 (FIG. 3). The biasing member 56 urges trocar 54 toits retracted position. The proximal end of trocar 54 includes atransverse slot 55 having a pin or rod 58 extending therethrough. Pin 58is slidably positioned within longitudinal slots 55 formed in bodyportion 52. The distal and proximal ends of slots 51 define the advancedand retracted positions of trocar 54, respectively.

Body portion 52 of anvil retainer assembly 50 includes an annularprotrusion 60 and defines a longitudinal slot 61. Annular protrusion 60facilitates attachment of anvil assembly 100 to anvil retainer assembly50 as will be discussed in further detail below. A cam member 62 ispivotally supported about a pivot member 64 in slot 61 at a positionproximal of pin 58. Cam member 62 includes a distal finger 62 a havingan angled face and a recess 63 positioned proximally of finger 62 a forreceiving pin 58 of trocar 54. Pin 58 is urged by coil spring 56 towardsfinger 62 a. Engagement between the angled face of finger 62 a and pin58 urges cam member 62 to pivot about pivot member 64 to allow pin 58 tomove into recess 63.

Referring now to FIGS. 5-7, anvil assembly 100 is configured forreleasable attachment to stapling device 10 (FIG. 1). Anvil assembly 100includes a head assembly 102 and a rod assembly 104. Head assembly 102is pivotally secured to rod assembly 104 and is configured toselectively move between a tilted position (FIG. 5) and an operativeposition (FIG. 21).

With particular reference to FIG. 7, head assembly 102 includes an anvilhead 110, an anvil post 120, a cutting ring 130, a cover 140, and ananvil plate 150. Rod assembly 104 includes an anvil center rod 160, afirst slide member 170, a second slide member 180, first and second linkmembers 190, 192 pivotally connecting first and second slide members170, 180 of rod assembly 104 with anvil post 120 of head assembly 102,and a spring member 196 for biasing first and second slide members 170,180 relative to each other.

With reference still to FIGS. 5-7, anvil head 110 of head assembly 102defines a centrally located throughbore 111 configured to receive anvilpost 120, an inner annular recess 113 configured to receive cut ring130, and an outer annular recess 115 configured to receive anvil plate150. Inner annular recess 113 and outer annular recess 115 are separatedby an annular flange 116 defines a notch 116 a. Anvil head 102 furtherdefines a first set of openings 117 a configured to receive a first orretaining suture “S₁” and a second set of openings 117 b configured toreceive a second or guide suture “S₂”. As will be described in furtherdetail below, first suture “S₁” is a component of tubular guide assembly202 of anvil delivery system 200 and second suture “S₂” is a componentof suture guide assembly 204 of anvil delivery system 200.

Anvil post 120 is configured to be secured within throughbore 111 ofanvil head 110. Anvil post 120 defines lateral slot 121 configured toaccommodate first and second link members 190, 192, a large transversebore 123 extending across longitudinal slot 121 for receiving a pivotmember 106, and a pair of small transverse bores 115 a, 115 b extendingacross longitudinal slot 121 for receiving pivot pins 106 a, 108 a,respectively. Pivot member 106 pivotally connects anvil post 120 to adistal end 160 b of center rod 160 via a cooperating bore 163 formed incenter rod 160. In one embodiment, pivot member 106 includes a pin orpost which defines a transverse axis which is spaced laterally from thelongitudinal axis “x” defined by center rod 160 such that anvil head 110can pivot approximately ninety degrees (90°) from an operative position(FIG. 21) in which a plane defined by tissue contacting surface 152 ofanvil plate 150 of head assembly 102 is substantially perpendicular tothe longitudinal axis “x” of center rod 160 to a tilted reduced profileposition (FIG. 28) in which head assembly 110 is substantially parallelto longitudinal axis “x” of center rod 160. Alternately, other types ofpivot members at a variety of locations in relation to longitudinal axis“x” of center rod 160 may be incorporated into anvil assembly 100. Pivotpins 106 a, 108 a pivotally connect first and second links 190, 192 ofrod assembly 104 with anvil post 120.

Referring also to FIGS. 5 and 7, cutting ring 130 defines a throughbore131 configured to be positioned about anvil post 112 and has a radialslot 133 configured to align with first set of openings 117 a in anvilhead 110. When cutting ring 130 is received within inner annular recess113 of anvil head 110, radial slot 133 is configured to accommodatesecond suture “S₂” of suture guide assembly 204 of anvil delivery system200 which is received through the second set of openings 117 b. Cover140 defines a throughbore 141 and is configured to be received betweencutting ring 130 and anvil plate 150. Cover 140 may be formed of Mylar®or other protective material.

Anvil plate 150 includes a tissue contacting surface 152 defining aplurality staple forming recesses 153. Anvil plate 150 further includesa tab 154 configured to be received within a slot 115 a formed in anvilhead 110. Tab 154 and slot 115 a cooperate to position anvil plate 150in the proper orientation within outer recess 115 of anvil head 110.

Referring to FIGS. 5-7, center rod 160 of rod assembly 104 includesproximal and distal ends 160 a, 160 b and defines a throughbore 161. Asshown, proximal end 160 a includes at least one opening 165 configuredto receive a suture or the like to facilitate positioning of anvilassembly 100 within a hollow organ. A distal end of throughbore 161 (seeFIG. 18) is configured to slidably receive at least a portion of each offirst and second slide members 170, 180.

With particular reference to FIG. 7, first slide member 170 of rodassembly 104 includes a substantially annular body having an openproximal end 170 a and a closed distal end 170 b and defining athroughbore 171 extending between proximal and distal ends 170 a, 170 b.Throughbore 171 is configured to accommodate spring member 196. Firstslide member 170 further defines a longitudinal cut-away 173 whichextends between proximal and distal ends 170 a, 170 b and is incommunication with throughbore 173. Cutaway 173 is configured toaccommodate second slide member 180 such that first and second slidemembers 170, 180 may slide relative to each other. Distal end 170 b offirst slide member 170 includes a radially outward extending flange 172defining a transverse bore 175 configured to receive pivot pin 106 b.Pivot pin 106 b secures a first end 190 a of first link 190 of rodassembly 104 to the first slide member 170. A second end 190 b of firstlink 190 is secured with anvil post 120 of head assembly 102 by a pivotpin 106 a. Distal end 170 b further includes a nub 174 extendingproximally within throughbore 171 configured to support and align adistal end 196 b of spring member 196 within throughbore 171.

Second slide member 180 of rod assembly 104 is configured forlongitudinal movement relative to first slide member 170. Second slidemember 180 includes a longitudinal body having a closed proximal end 180a, an open distal end 180 b, and is configured to be received in thecut-away 173 of first slide member 170. As noted above, thisconfiguration permits sliding of first slide member 170 in relation tosecond slide member 180. A radially outward extending flange 182 extendsalong a majority of the length of second slide member 180 and defines atransverse bore 185 configured to receive pivot pin 108 b for securingsecond link 192 of rod assembly 104 with anvil post 120 of head assembly102. A proximal end 180 a of second slide member 180 includes a distallyextending nub 184 which supports and aligns a proximal end 196 a ofspring member 196 within throughbore 171.

A spring or biasing member, e.g., coil spring 196, is positioned betweenfirst and second slide members 170, 180 to urge the slide members apartor away from each other. First or drive link 190 is pivotally connectedat a proximal end 190 a to second slide member 180 by pivot pin 106 aand is pivotally connected at a distal end 190 b to anvil post 120 bypivot pin 106 b. Second or return link 192 is pivotally connected at aproximal end 192 a to first slide member 170 by pivot pin 108 a and ispivotally connected at a distal end 192 b to anvil post 120 by pivot pin108 b. First and second links 190, 192 are connected to slide members170, 180 and anvil post 120 in such a manner that when biasing member196 urges first and second slide members 170, 180 apart, anvil head 110pivots about pivot member 106 to its tilted reduced profile position(FIG. 28).

Center rod 160 includes a plurality of flexible arms 164 which defines aproximal end of throughbore 161 and is configured to releasably engage aremovable trocar, adaptor and/or the annular protrusion 60 of the bodyportion 52 of the anvil retainer assembly 50. A plurality of splines 166are formed about center rod 160. Splines 166 mesh with grooves (notshown) formed in stapling device 10 (FIG. 1) to properly align anvilassembly 100 in relation to shell assembly 30 (FIG. 3) of staplingdevice 10 during approximation of anvil assembly 100 and shell assembly30.

In any of the embodiments disclosed herein, the pivoting anvil assembly,which includes a head assembly and a rod assembly, may be arrangeddifferently. For example, see the tilting anvil assembly disclosed inU.S. patent application Ser. No. 13/915,953, the disclosure of which ishereby incorporated by reference herein in its entirety.

With reference now to FIGS. 8 and 9, anvil assembly 100 is shownoperably connected to a system for delivering anvil assembly 100 withina patient “P” (FIG. 25) shown generally as anvil delivery system 200.Anvil delivery system 200 includes a tubular guide assembly 202 and asuture guide assembly 204. Each of tubular and suture guide assemblies202, 204 are selectively secured to anvil assembly 100 to facilitatetrans-oral positioning of anvil assembly 100 within a patient. As willbe described in further detail below, tubular guide assembly 202 isconfigured to be manually detached from anvil assembly 100 prior toattachment of anvil assembly 100 to stapling device 10 (FIG. 1) andsuture guide assembly 204 is configured to be automatically detachedfrom anvil assembly 100 following the stapling stroke of the staplingdevice 10 (FIG. 1).

With reference now to FIGS. 8-12, tubular guide assembly 202 includes aflexible tube 210 for trans-oral positioning of anvil assembly 100within a patient “P” (FIG. 20) and an adapter 220 for connectingflexible tube 210 to anvil assembly 100. Flexible tube 210 includes anopen end 210 a for supporting adapter 220 and a closed end 210 bconfigured for trans-oral receipt in a patient. Open end 210 a offlexible tube 210 defines a throughbore 211 configured to receive alocking pin 214. Open end 210 a further eludes an opening 213. Flexibletube 210 may include markings or other gradations 216 (FIG. 11) alongthe length thereof to indicate to a surgeon the depth of insertion ofthe flexible tube 210 within the patient during tran-oral positioning ofanvil assembly 100 within a patient and/or to indicate the length offlexible tube 210 remaining in the patient during removal.

Adapter 220 includes a first end 220 a configured to be received withinopen end 210 a of flexible tube 210 and a second end 220 b configured tobe received within bore 161 formed in center rod 160 of anvil assembly100. A first end 220 a of adapter 220 includes a series of annular rings222 configured to frictionally retain first end 220 a of adapter 220within open end 210 a of flexible tube 210. A second end 220 b ofadapter 220 includes a longitudinal guide member 224 configured to bereceived between two adjacent flexible arms 164 of center rod 160 ofanvil assembly 100. Second end 220 b of adapter 220 is sized to allowcenter rod 160 of anvil assembly 100 to freely slide onto and off ofsecond end 220 b of adapter 220. Adapter 220 further defines a firstthroughbore 221 formed in a central hub portion 226 as well as secondand third throughbores 223, 224 formed in first end 220 a. Throughbore223 is configured to align with throughbore 211 formed in open end 210 aof flexible tube 210 and is sized to receive locking pin 214.Throughbore 223 is configured to receive both ends of the first suture“S₁.” Throughbore 221 can also receive the suture ends to enhanceretention. For a more detailed description of an exemplary tubular guideassembly including a flexible tube and an adapter, please refer tocommonly owned U.S. Pat. No. 8,109,426, the content of which isincorporated by reference herein in its entirety.

In order to secure anvil assembly 100 on tubular guide assembly 202 ofanvil delivery system 200, first suture “S₁” is threaded throughopenings 117 a formed on anvil head 110 such that first and second endsof first suture “S₁” are positioned on different sides of center rod160. Second end 220 b of adapter 220 is positioned within throughbore161 of center rod 160 such that longitudinal guide 224 (FIG. 10) ofadapter 220 is received between two arm members 164 (FIG. 7) of centerrod 160. Each of the first and second ends of first suture “S₁” is theninserted through throughbore 223 formed in adapter 220. Anvil head 110is then rotated to a first tilted position against the bias of spring196 and the first and second ends of first suture “S₁” are pulledthrough opening 223 to apply tension on anvil head 110 to retain anvilhead 110 in the first tilted position as shown in FIG. 12.

After first suture “S₁” is tensioned to retain anvil head 110 in thefirst tilted position, first end 220 a of adapter 220 is inserted intoopen end 210 a of flexible member 210. The frictional contact betweenannular rings 222 of first end 220 a of adapter 220 and an inner surfaceof flexible tube 210 secures adapter 220 to flexible tube 210 andprevents first suture “S₁” from loosening as it is clinched between theouter wall of the adapter 220 and inner all of flexible tube 210. It isenvisioned that more than one suture may be used to secure anvil headassembly 110 in a pre-fired tilted position. It is also envisioned thatfirst suture “S₁” need not be passed through bore 221 but instead canclamped between adapter 220 and the inner wall of the flexible tube 210.

Turning back to FIG. 9, suture guide assembly 204 of anvil deliverysystem 200 includes a reel assembly 230. Reel assembly 230 is configuredto house and facilitate manipulation of second suture “S₂”. Reelassembly 230 includes a housing 240 and a reel member 250.

With reference now to FIGS. 13 and 14, housing 240 of reel assembly 230includes a substantially circular body 242 defining an annular cavity orrecess 241. Circular body 242 may include a textured surface tofacilitate operable engagement by a user, e.g. ribs 242 a (FIG. 13).Housing 240 further includes a radially outward extending tab 244 and anannular flange 246. Tab 244 defines an opening 243 and a pair of slots245. Opening 243 is configured to receive second suture “S₂” andoperates to guide second suture “S₂” from reel member 250 (FIG. 15).Slots 245 are configured to selectively receive and secure second suture“S₂” once a sufficient length of second suture “S₂” is released fromreel member 250.

Turning to FIGS. 15 and 16, reel member 250 of reel assembly 230includes a substantially circular body 252 defining an annular recesses251 extending about an outer perimeter 254 of circular body 252. Annularrecess 253 is configured to receive second suture “S₂”. Circular body252 further defines an opening 253 configured to operably receiveannular flange 246 of housing 240 such that circular body 252 isrotatably supported within annular cavity 241 of a housing 240. Circularbody 252 is rotatably supported within housing 240 to permit the releaseof second suture “S₂” from within annular recess 251 of reel member 250.

Referring to FIGS. 17-19, suture guide assembly 204 of anvil deliverysystem 200 is shown operably attached to anvil assembly 100. Althoughsuture guide assembly 204 may be provided to a clinician pre-attached toanvil assembly 100, is envisioned that suture guide assembly 204 andanvil assembly 100 may be provided as separate components that can beattached to one another by a clinician prior to use. Second suture “S₂”is attached to anvil assembly 100 by threading an end of second suture“S₂” into a first opening of second openings 117 b of anvil head 110,through slot 133 of cutting ring 130 and notch 116 a of anvil head 110,and out a second opening of second openings 117 b. First and second endsof second suture “S₂” are then threaded through opening 243 formed intab 244 of housing 240 of reel assembly 230 and secured about reelmember 250 of reel assembly 230. To secure second suture “S₂” to reelmember 250, second suture “S₂” is wound in annular recess 251 about reelmember 250. Reel member 250 is then secured to housing 240 bypositioning reel member 250 within annular cavity 241 of housing 240 andpositioning flange 246 of housing 240 within opening 253 of reel member250.

With reference now to FIG. 20, a method for delivering anvil assembly100 to a surgical site within a patient will be described. In onemethod, anvil assembly 100 is provided in the first tilted positionsupported on tubular guide member 202 of anvil delivery system 200 andsuture guide assembly 204 is attached to anvil head 110 such that anvilassembly 100 is ready for delivery. Alternatively, the suture guideassembly 204 and tubular guide assembly 202 can be provided separatelyfrom anvil assembly 100 and a clinician can secure anvil assembly 100 totubular guide assembly 202 and/or suture guide assembly 204 of anvildelivery system 200 as discussed above. In this manner, tubular guideassembly 202, suture guide assembly 204, and/or anvil assembly 100 maybe provided to a clinician as separate components, or together as kit.Once flexible tube 210 of tubular guide assembly 202 has been secured toanvil assembly 100 and second suture “S₂” of suture guide assembly 204has been attached to anvil assembly 100, the surgeon inserts closed end210 b of flexible tube 210 in the patient's mouth “M” and moves closedend 210 b along with flexible tube 210 down through esophagus “E” to asurgical site, e.g., the stomach “St”. As anvil assembly 100 travelsthrough esophagus “E” to the surgical site, second suture “S₂” isunwound from reel assembly 230 of suture guide assembly 204. Sutureguide assembly 204 may be used at any point during insertion and priorto completion of the stapling procedure to retract anvil assembly 100back through esophagus “E” and out of the patients mouth “M”. Sutureguide assembly 204 may also be used to manipulate anvil assembly 100 inthe event anvil assembly 100 becomes stuck and/or, is not properlypositioned within the patient “P”.

After insertion, the surgeon then makes a first incision “I₁” at thesurgical site (stomach “St” as shown) to provide access to closed end210 b of flexible tube 210. Thereafter, the surgeon pulls open end 52 bof flexible tube 52 through first incision “I₁” to position the anvilassembly 100 at the surgical site. In some procedures it may bebeneficial to pull flexible tube 210 through incision “I₁” until centerrod assembly 104 of anvil assembly 100 advances through first incision“I₁”. When anvil assembly 100 is properly positioned at the surgicalsite, the surgeon releases tubular guide assembly 202 of anvil deliverysystem 200 from anvil assembly 100 by cutting suture “S₁” and separatinganvil assembly 100 from second end 20 b of adapter 220. Flexible tube210 and adapter 220 may then be pulled from the body through firstincision “I₁”. Second suture “S₂” of suture guide assembly 204 may alsobe secured within slots 245 formed in tab 244 of housing 240 of reelassembly 230.

In one method, a second incision “I₂” is then formed at the surgicalsite such that distal head portion 16 of stapling device 10 may bereceived therethrough. Alternatively, distal head portion 16 of staplingdevice 10 may be received through first incision “I₁” once tubular guideassembly 202 of anvil deliver system 200 has been removed therefrom.

Referring to FIGS. 21 and 22, after stapling device 10 and anvilassembly 100 are positioned at the surgical site, anvil assembly 100 canbe secured to stapling device 10 by inserting retractable trocar 54 intobore 161 of center rod 160 of anvil assembly 100. Because the anvilretainer assembly 50 is unapproximated when anvil assembly 100 isattached and stapling device 10 (FIG. 1) has yet to be fired, trocar 54is in its advanced position. When trocar 54, in its advanced position,is inserted into center rod throughbore 161, tip 54 b of trocar 52engages base portion 182 of second slide member 180 and moves secondslide member 180 towards first slide member 170 to move anvil head 110from its tilted position to its operative, non-tilted position via links190, 192 with anvil head 110 in its operative position, tissue toanastomosed can be secured about anvil center rod 160 using knowntechniques.

Referring to FIGS. 23 and 24, when the anvil assembly 100 and shellassembly 30 are approximated, cam member 62 is prevented from pivotingby bushing 44 and arms 43 of pusher 40. Since cam member 62 is not freeto pivot, finger 62 a is positioned to prevent pin 58 from movingproximally within body portion 52 of anvil retainer assembly 50 toprevent retraction of trocar 54. As such, trocar tip 54 b engages secondslide member 180 to retain second slide member 180 in its advancedposition. As such, anvil head 102 is retained in the operative,non-tilted position.

With reference now to FIG. 25, stapling device 10 (FIG. 1) may then befired. During firing of stapling device 10, knife blade 38 mountedwithin shell assembly 30 on distal end portion 16 of stapling device 10is advanced distally into engagement with head assembly 102 of anvilassembly 100. In some embodiments, knife blade 38 can be advancedsubsequent to and/or independently of pusher 40. Distal advancement ofknife blade 38 causes knife blade 38 to pass through cover 140 and intocutting ring 130 of anvil assembly 100. As knife blade 38 engagescutting ring 130, second suture “S₂” which is received within slot 133of cutting ring 130 is severed. As such, second suture “S₂” and sutureguide assembly 204 is disconnected from anvil assembly 100. As notedabove, prior to firing of stapling device 10 (FIG. 1), suture guideassembly 204 may be used to facilitate position of anvil assembly 100and/or to retract anvil assembly 100 back through the patient's mouth“M” (FIG. 20). By severing second suture “S₂”, second suture “S₂” doesnot need to be retracted through second openings 117 b (FIG. 19) todetach second suture “S₂” from anvil assembly 100. This reduces thelikelihood of any tissue damage caused by friction while retractingsecond suture “S₂” from head assembly 102. Further, by not having toretract second suture “S₂” through second openings 117 b in headassembly 102 of anvil assembly 100, the likelihood of introducingbacteria or other foreign material into the patient is reduced.

Referring to FIGS. 26 and 27, when stapling device 10 (FIG. 1) is firedand pusher 40 is moved distally about bushing 44, arms 43 of pusher 40are deformed outwardly away from cam member 62. Engagement between pin58 and the angled face of finger 62 a causes cam member 62 to pivot.When cam member 62 pivots, pin 58 moves proximally into recess 63 of cammember 62 and trocar 54 moves to its retracted position withinlongitudinal bore 53 of body portion 52 under the bias of spring 56. Astrocar 54 moves to its retracted position, biasing member 196 urgesfirst and second slide members 170, 180 apart to urge anvil head 110 toits tilted reduced profile position (see FIG. 28). Because of theproximity of anvil head 110 to shell assembly 30, anvil head 110 willonly move to its tilted reduced profile position during unapproximationof anvil assembly 100 and shell assembly 30. Anvil assembly 100 may thenbe removed from the surgical site and the surgical procedure may becompleted in a traditional manner.

In further embodiments, the suture can be attached to the anvil assemblyat a location that is not near the knife or cut ring. In this way, theknife does not sever the suture. The procedure is carried out asdiscussed above, except that one leg only of the suture is cut and thenthe suture guide assembly and suture are removed. Then, the anvilassembly is attached to the instrument, attachment actuating themovement of the anvil away from the tilted position, and the instrumentis fired. Firing initiates movement of the anvil from the operativeposition back to the tilted position.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, the slotted cutting ring maybe incorporated into anvil assemblies having alternative configurations.Therefore, the above description should not be construed as limiting,but merely as exemplifications of preferred embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

What is claimed is:
 1. An anvil assembly comprising: an anvil centerrod; and a head assembly secured to the anvil center rod, the headassembly including an anvil head and a cutting ring disposed within theanvil head, wherein the cutting ring includes a cutting surfaceconfigured for operable engagement with a knife; and a guide suturedisposed across the cutting surface of the cutting ring, the guidesuture being configured for trans-oral retrieval of the anvil assemblyprior to engagement of the knife with the cutting surface.
 2. The anvilassembly of claim 1, wherein the head assembly is pivotally secured tothe anvil center rod about a pivot axis and movable between an operativeposition and a tilted position.
 3. The anvil assembly of claim 2,wherein the anvil center rod includes first and second slide members,the first slide member being pivotally connected to the head assembly onone side of the pivot axis by a first drive link and the second slidemember being connected to the head assembly on the other side of thepivot axis by a second drive link, the first slide member being movablein relation to the second slide member to effect movement of the headassembly between the operative position and the tilted position.
 4. Theanvil assembly of claim 3, further including a biasing member positionedto urge the first slide member in relation to the second slide member toposition the head assembly in the tilted position.
 5. The anvil assemblyof claim 4, wherein the biasing member is positioned between the firstmember and the second slide member to urge the first and second slidemembers apart.
 6. The anvil assembly of claim 2, further comprising ananvil tilting mechanism.
 7. The anvil assembly of claim 1, wherein theanvil head defines first and second openings and the guide suture isreceived through the first and second openings.
 8. The anvil assembly ofclaim 7, wherein the cutting surface of the cutting ring defines a slot,the guide suture being received within the slot.
 9. The anvil assemblyof claim 8, wherein the guide suture is received through the firstopening in the anvil head, passes through the slot in the cutting ring,and extends from the second opening in the anvil head.
 10. The anvilassembly of claim 1, further including a suture guide assembly includinga reel member secured to the guide suture.
 11. The anvil assembly ofclaim 10, wherein the reel assembly includes a housing and a reel memberrotatably received within the housing, wherein the guide suture issupported about the reel member.
 12. The anvil assembly of claim ofclaim 1, wherein the guide suture extends from the housing assembly awayfrom the anvil center rod.
 13. A surgical stapling apparatus comprising:a shell assembly including a knife movable between a retracted positionand an extended position; and an anvil assembly selectively securedrelative to the shell assembly, the anvil assembly including a headassembly configured to be engaged by the knife, and a guide suturereceived through the head assembly and configured for trans-oralretrieval of the anvil assembly prior to movement of the knife to theextended position, wherein the head assembly is configured such thatmovement of the knife from the retracted position to the extendedposition severs the guide suture.
 14. The surgical stapling apparatus ofclaim 13, wherein the anvil assembly further includes a center rodassembly and the head assembly is pivotally secured to the center rodassembly and is movable between an operative position and a tiltedposition.
 15. The surgical stapling apparatus of claim 14, wherein thehead assembly includes an anvil head, the anvil head defining first andsecond openings through which the guide suture is received.
 16. Thesurgical stapling apparatus of claim 15, wherein the head assemblyfurther includes a cutting ring received with the anvil head, thecutting ring includes a cutting surface configured to be engaged by theknife, wherein the guide suture extends across the cutting surface. 17.The surgical stapling apparatus of claim 16, wherein the cutting surfaceof the cutting ring defines a slot, the guide suture being receivedwithin the slot.
 18. The surgical stapling apparatus of claim 13,wherein the guide suture extends from the housing assembly away from theshell assembly.
 19. An anvil assembly comprising: an anvil center rod;and a head assembly secured to the anvil center rod, the head assemblyincluding an anvil head and a cutting ring disposed within the anvilhead, wherein the cutting ring includes an annular surface configuredfor operable engagement with a knife, the annular surface defining aninner perimeter and an outer perimeter; and a suture retained in aposition extending across the annular surface of the cutting ring fromthe inner perimeter to the outer perimeter, the suture being configuredfor trans-oral retrieval of the anvil assembly prior to engagement ofthe knife with the annular surface.